NCT00935883

Brief Summary

To evaluate the safety and efficacy of eculizumab for the treatment of dry AMD as evaluated by the change in drusen volume and area of geographic atrophy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 26, 2015

Completed
Last Updated

May 30, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

July 7, 2009

Results QC Date

December 4, 2014

Last Update Submit

April 29, 2017

Conditions

Age-Related Macular Degeneration

Keywords

Age Related macular DegenerationMacular DegenerationDrusenGeographic atrophyEculizumabSoliris

Outcome Measures

Primary Outcomes (2)

  • Growth of Geographic Atrophy

    6 months

  • Decrease in Drusen Volume

    6 Months

Secondary Outcomes (2)

  • Change in Visual Acuity for Drusen Group

    Baseline/ 6 Months

  • Change in Visual Acuity for Geographic Atrophy Group

    Baseline/ 6 Months

Study Arms (2)

Saline

PLACEBO COMPARATOR

Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator

Drug: Saline

Eculizumab

ACTIVE COMPARATOR

Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab

Drug: Eculizumab

Interventions

EculizumabDRUG

Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days). Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24. Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months.

Also known as: Soliris
Eculizumab
SalineDRUG

Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days). Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24. Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months.

Also known as: PBS
Saline

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age \> 50 years
  • In the study eye(s), the presence of non-exudative AMD documented by fundus photography, autofluorescence, fluorescein angiography, and spectral domain OCT.
  • Visual acuity of 20/63 or better (BCVA score of at least 59 letters) as measured on an ETDRS chart.
  • Able and willing to comply with study procedures.

You may not qualify if:

  • Visual acuity worse than 20/63
  • Any history of choroidal neovascularization in the study eye
  • Unresolved meningococcal disease.
  • Confounding ocular conditions such as amblyopia; aphakia; myopia requiring \>6 diopters of correction; pigment epithelial detachment; uncontrolled glaucoma (intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication); steroid-induced ocular hypertension; retinal inflammatory disease; central serous choroidopathy; prior or current retinal detachment; macular edema; cystic lesion (individual cysts or cystoid macular edema); ocular herpes simplex virus; severe non-proliferative or worse diabetic retinopathy; anterior ischemic optic neuropathy; RPE tear involving the macula; pseudovitelliform macular degeneration; vitreo-retinal traction maculopathy; vitreous hemorrhage, history of or current rhegmatogenous retinal detachment or macular hole; uveitis; diffuse choroidal atrophy; optic atrophy (as evidenced by pallor); intraocular inflammation; ocular or periocular infection; moderate or worse dry eye syndrome; clinically significant cataract or opacification of the posterior capsule which, in the Investigator's opinion, would progress during the course of the study and could affect central vision; other ocular conditions that the Investigator believes may be a confounding factor in this study
  • Refusal to be vaccinated against Neisseria meningitides or an active Neisseria meningitides infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Related Publications (4)

  • Yehoshua Z, de Amorim Garcia Filho CA, Nunes RP, Gregori G, Penha FM, Moshfeghi AA, Zhang K, Sadda S, Feuer W, Rosenfeld PJ. Systemic complement inhibition with eculizumab for geographic atrophy in age-related macular degeneration: the COMPLETE study. Ophthalmology. 2014 Mar;121(3):693-701. doi: 10.1016/j.ophtha.2013.09.044. Epub 2013 Nov 26.

    PMID: 24289920RESULT

  • Garcia Filho CA, Yehoshua Z, Gregori G, Nunes RP, Penha FM, Moshfeghi AA, Zhang K, Feuer W, Rosenfeld PJ. Change in drusen volume as a novel clinical trial endpoint for the study of complement inhibition in age-related macular degeneration. Ophthalmic Surg Lasers Imaging Retina. 2014 Jan-Feb;45(1):18-31. doi: 10.3928/23258160-20131217-01.

    PMID: 24354307RESULT

  • Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.

    PMID: 37314061DERIVED

  • Stetson PF, Yehoshua Z, Garcia Filho CA, Portella Nunes R, Gregori G, Rosenfeld PJ. OCT minimum intensity as a predictor of geographic atrophy enlargement. Invest Ophthalmol Vis Sci. 2014 Feb 10;55(2):792-800. doi: 10.1167/iovs.13-13199.

    PMID: 24408973DERIVED

MeSH Terms

Conditions

Macular DegenerationGeographic Atrophy

Interventions

eculizumabSodium Chloride

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Philip J Rosenfeld
Organization
University of Miami Miller School of Medicine
prosenfeld@med.miami.edu
305-326-6148

Study Officials

  • Philip J Rosenfeld, MD, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 9, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2012

Study Completion

August 1, 2013

Last Updated

May 30, 2017

Results First Posted

January 26, 2015

Record last verified: 2017-04

Locations

US(1)